License and Transfer Agreement for IL-21 Protein

“[    *    ]” = omitted, confidential material, which material has been separately filed with the Securities and Exchange Commission pursuant to a request for confidential treatment.

Exhibit 10.2

License and Transfer Agreement for IL-21 Protein

This License and Transfer Agreement for IL-21 Protein (“ Agreement ”) is effective as of January 16, 2009 (the “ Effective Date ”) and is entered into by and between ZymoGenetics, Inc., a Washington corporation having a principal place of business at 1201 Eastlake Avenue East, Seattle, Washington 98102 (“ ZGEN ”), and Novo Nordisk A/S, a Danish corporation having a principal place of business at Novo Alle, DK-2880, Bagsvaerd, Denmark (“ NN ”).

WHEREAS, ZGEN and NN are parties to a certain Restated License Agreement for IL-21 effective as of January 1, 2003, which was amended and restated by the Second Restated License Agreement effective as of January 16, 2009;

WHEREAS, ZGEN and NN are parties to a certain Collaborative Data Sharing and Cross-License Agreement for IL-21 Protein (“ Cross-License Agreement ”) effective as of August 11, 2005, which has been terminated as of the Effective Date pursuant to a letter agreement (“ Cross-License Letter Agreement ”), which Cross-License Letter Agreement provides for the survival of certain provisions of the Cross-License Agreement;

WHEREAS, NN desires to cease development of the IL-21 Protein;

WHEREAS, ZGEN has retained all rights in NA for IL-21 Protein and desires to develop and commercialize IL-21 Protein in the RoW as well;

WHEREAS, ZGEN is interested in obtaining rights to NN’s data, Regulatory Submissions and Product Approvals, intellectual property, and other information generated pursuant to the Cross-License Agreement or otherwise related to the research and development of IL-21 Protein, pursuant to the terms of this Agreement;

WHEREAS, NN is willing to return its rights to IL-21 Protein formerly granted by ZGEN to NN while maintaining rights to remaining IL-21 Embodiments, as well as grant ZGEN worldwide access and rights to NN’s data, Regulatory Submissions and Product Approvals, intellectual property, and other information generated pursuant to the Cross-License Agreement or otherwise related to the research and development of IL-21 Protein, pursuant to the terms of this Agreement; and

WHEREAS, ZGEN is willing to compensate NN for return of RoW IP rights to IL-21 Protein, in exchange for obtaining rights to NN’s data, Regulatory Submissions and Product Approvals, intellectual property, and other information generated pursuant to the Cross-License Agreement or otherwise related to the research and development of IL-21 Protein, in each case pursuant to the terms of this Agreement.

NOW THEREFORE, IT IS HEREBY AGREED AS FOLLOWS:

 

ARTICLE 1

Definitions

SECTION 1.1. “ Affiliate ” means: with respect to a party, any other business entity which directly or indirectly controls, is controlled by or is under common control with the party. The direct or indirect ownership of at least fifty percent (50%) or, if smaller, the maximum allowed by applicable law, of the voting securities of a business entity or of an interest in the assets, profits or earnings of a business entity shall be deemed to constitute control of the business entity. For the avoidance of doubt, ZGEN and NN are not Affiliates of each other. Notwithstanding the above, the Novo Nordisk Foundation, Novo A/S and Novozymes A/S shall not be considered Affiliates of NN.

SECTION 1.2. “ Agency ” means: the FDA, EMEA or foreign equivalent of either.

SECTION 1.3. “ Approval ” means: any approval, registration, license or authorization from any Regulatory Authority required for the clinical trials or the marketing of a Product, including, without limitation, an approval, registration, license or authorization granted in connection with any Regulatory Submission.

SECTION 1.4. “ Assignee Party ” shall have the meaning set forth in SECTION 10.1.

SECTION 1.5. “ Assigning Party ” shall have the meaning set forth in SECTION 10.1.

SECTION 1.6. “ BLA ” or “ PLA ” means: a biologics license application or product license application filed with an Agency pursuant to the Agency’s regulations, including all amendments and supplements to the application, and any equivalent foreign filing with a Regulatory Authority.

SECTION 1.7. “ Breaching Party ” shall have the meaning set forth in SECTION 8.4.

SECTION 1.8 “ CEO ” means: chief executive officer.

SECTION 1.9 “ Claim(s) ” shall have the meaning set forth in SECTION 7.1.

SECTION 1.10 “ Collaborative Agreement ” means: the Collaborative Agreement for IL-21 effective as of December 14, 2002, between ZGEN and NN.

SECTION 1.11. “ Commercialization Partner ” means: a Sublicensee to whom ZGEN has extended certain commercialization rights that it received or reserved under this Agreement including the right to develop, promote, market, offer to sell, import, export, distribute, sell or have sold Products as part of a co-marketing agreement, co-commercialization agreement, strategic partnership, joint venture relationship or the like with ZGEN.

SECTION 1.12. “ Common Product ” means: a Product having as an active agent the IL-21 Protein identified as [    *    ].

 

SECTION 1.13. “ Confidential Information ” means: information disclosed pursuant to this Agreement including all proprietary information and materials, patentable or otherwise, of a party that is disclosed by or on behalf of such disclosing party to the receiving party or its Affiliates, such as DNA sequences, amino acid sequences, vectors, cells, substances, formulations, techniques, methodology, equipment, plans, data, reports, know-how, assay results, preclinical studies and clinical trials and the results thereof, patent positioning and business plans, including negative developments.

SECTION 1.14. “ Controls ” and “ Controlled ” mean: the entity referenced has the ability to exploit and to license or sublicense the right to exploit the referenced technology or rights, without (assuming the timely payment of all applicable royalties) violating the terms of any agreement or other arrangement between the entity referenced and a third party.

SECTION 1.15 “ CRO ” means: contract research organization.

SECTION 1.16: “ Cross-License Agreemen t” means: the Collaborative Data Sharing and Cross-License Agreement for IL-21 Protein, effective as of August 11, 2005, between ZGEN and NN.

SECTION 1.17. “ Cross-License Letter Agreement ” means: the Letter Agreement between ZGEN and NN regarding Termination of the Cross License Agreement, entered into as of the Effective Date.

SECTION 1.18. “ EMEA ” means: the European Medicines Evaluation Agency or any successor agency thereto.

SECTION 1.19. “ FDA ” means: the United States Food and Drug Administration or any successor agency thereto.

SECTION 1.20. “ Force majeure ” shall have the meaning set forth in SECTION 10.6.

SECTION 1.21. “ IL-21 Antagonist Protein ” means: a protein, and all species, fragments and modifications of such polypeptide sequence, encoded by an IL-21 Gene that act solely as (i) an antagonist protein on the IL-21 receptor (i.e., such protein binds the receptor but does not illicit receptor signaling), and (ii) competitively inhibits the binding of IL-21 Protein on the IL-21 receptor.

SECTION 1.22. “ IL-21 Embodiment ” shall have the meaning as defined in the Second Restated License Agreement.

SECTION 1.23. “ IL-21 Gene ” means: the polynucleotide sequence identified in [    *    ], and all species, fragments and modifications of such polynucleotide sequence that are disclosed in such application or any patents or patent applications included in Appendix A and Appendix C.

SECTION 1.24. “ IL-21 Protein ” means: the protein identified in [    *    ] and any protein encoded by an IL-21 Gene and all species, fragments and modifications of such polypeptide sequence that are disclosed in such application or any patents or patent applications included in Appendix A and Appendix C. For the avoidance of doubt, IL-21 Protein includes the Common

 

Product. Notwithstanding the above, any IL-21 Antagonist Protein shall be expressly excluded from the definition of IL-21 Protein.

SECTION 1.25. “ IL-21 ZGEN Know-How ” means: all inventions, discoveries, know-how, methodologies, technology, data and tangible materials (including nucleic acids, peptides, vectors, proteins, cells, cell lines, transgenic and knock-out animals, and the like) that: (a) relate to an IL-21 Gene, IL-21 Protein or Common Product; (b) were invented, discovered, developed or otherwise generated by ZGEN or its Affiliates as of the Effective Date and (c) are Controlled by ZGEN or its Affiliates as of the Effective Date.

SECTION 1.26. “ IL-21 ZGEN Patent Rights ” means: (a) the patents and patent applications set forth in Appendix C appended hereto; (b) patents and patent applications Controlled by ZGEN or its Affiliates that claim an invention with a date of conception as of the Effective Date and that specifically recite as a claim element (i) an IL-21 Gene, IL-21 Protein or Product, (ii) a process, formulation and/or mixture comprising an IL-21 Gene, IL-21 Protein or Product, (iii) a method of making or manufacturing an IL-21 Protein or Product or (iv) a method of using an IL-21 Gene, IL-21 Protein or Product; (c) all divisional or continuation (in whole or in part) applications of the applications in described in (a) and (b); (d) all patents issuing from the applications described in (a), (b) and (c); and (e) all extensions, supplemental protection certificates (including any form of patent term extensions), reissues, reexaminations, substitutions or renewals of the patents described in (d). Notwithstanding the foregoing, if any portion of any application or patent described above does not specifically recite an IL-21 Gene, IL-21 Protein or Product as a claim element, then such portion of the application or patent is expressly excluded from the term “IL-21 ZGEN Patent Rights” but only to the extent that such portion does not claim an IL-21 Gene, IL-21 Protein or Product.

SECTION 1.27. “ IMPD ” means: an Investigational Medicinal Product Dossier application or its foreign equivalent.

SECTION 1.28. “ IND ” means: an Investigational New Drug application or its foreign equivalent.

SECTION 1.29. “ JPT ” shall have the meaning as set forth in SECTION 1.34 of the Cross-License Agreement.

SECTION 1.30. “ JSC ” shall have the meaning as set forth in SECTION 1.35 of the Cross-License Agreement.

SECTION 1.31. “ Know-How Product ” means: a product in final dosage form that contains an IL-21 Protein as an active agent and is not a Patent Product but that was developed through use of any Licensed Patent, Licensed Know-How, IL-21 ZGEN Patent Right or IL-21 ZGEN Know-How, or which otherwise incorporates or embodies Licensed Know-How or IL-21 ZGEN Know-How.

SECTION 1.32. “ Licensed Know-How ” means: all inventions, discoveries, know-how, methodologies, technology, data and tangible materials (including nucleic acids, peptides,

 

vectors, proteins, cells, cell lines, transgenic and knock-out animals, and the like), trade secrets, technical reports and data (including non-clinical data, preclinical data, toxicological studies, methods of synthesis, methods of production or manufacture, assay information and clinical trial data) concerning a Product Controlled by NN as of the Effective Date that are necessary to make, have made, use or sell a Product.

SECTION 1.33. “ Licensed Patents ” means: (a) the patents and patent applications set forth in Appendix A appended hereto; (b) all worldwide patents and patent applications Controlled by NN as of the Effective Date that specifically recite as a claim element (i) an IL-21 Gene, IL-21 Protein or Product, (ii) a process, formulation and/or mixture comprising an IL-21 Gene, IL-21 Protein or Product, (iii) a method of making or manufacturing an IL-21 Protein or Product or (iv) a method of using an IL-21 Gene, IL-21 Protein or Product; (c) all divisional or continuation (in whole or in part) applications of the applications in described in (a) and (b); (d) all patents issuing from the applications described in (a), (b) and (c); and (e) all extensions, supplemental protection certificates (including any form of patent term extensions), reissues, reexaminations, substitutions or renewals of the patents described in (d). Notwithstanding the foregoing, if any portion of any application or patent described above does not specifically recite an IL-21 Gene, IL-21 Protein or Product as a claim element, then such portion of the application or patent is expressly excluded from the term “Licensed Patents” but only to the extent that such portion does not claim an IL-21 Gene, IL-21 Protein or Product.

SECTION 1.34. “ MAA ” means: a Marketing Authorization Application or its foreign equivalent.

SECTION 1.35. “ Master Services Agreements ” means: collectively (i) the Master Agreement for Pharmaceutical Services effective as of March 10, 2004 between ZGEN and NN, and (ii) the Master Services Agreement for Clinical Manufacturing and CMC Development Services relating to IL-21 effective as of January 5, 2007 between ZGEN and NN and (iii) the Quality Agreement for Clinical Manufacturing and CMC Development Services relating to IL-21 effective as of January 5, 2007 between ZGEN and NN.

SECTION 1.36. “ Master Services Letter Agreement ” means: the Letter Agreement between ZGEN and NN regarding Termination of the Master Services Agreements and work orders related thereto, entered into as of the Effective Date.

SECTION 1.37. “ Milestone Fees ” shall have the meaning set forth in SECTION 4.2.

SECTION 1.38. “ NA ” means: Canada, Mexico and the United States of America and its territories and possessions.

SECTION 1.39. “ NN’s Existing Regulatory Submissions ” means: the Regulatory Submissions filed by NN prior to the Effective Date.

SECTION 1.40. “ NN Prosecuted Patents ” shall have the meaning set forth in SECTION 3.4(b).

SECTION 1.41. “ Non-Breaching Party ” shall have the meaning set forth in SECTION 8.4.

 

SECTION 1.42. “ Ongoing Clinical Trials ” means: NN’s clinical trials for the Common Product identified in Appendix B.

SECTION 1.43. “ Patent Product ” means: a product in final dosage form that contains an IL-21 Protein as an active agent the making, using, importation, exportation, offer for sale, or sale of which would infringe any unexpired Valid Claim of a Licensed Patent or IL-21 ZGEN Patent Right.

SECTION 1.44. “ Process Development Agreement ” means: the Agreement to Exchange Process Development Data for IL-21 Protein effective as of March 3, 2004, between ZGEN and NN.

SECTION 1.45. “ Product ” means: either a Patent Product or a Know-How Product.

SECTION 1.46. “ Product Approval ” means: the Approval from any Regulatory Authority on a Product specifically granted in connection with the Regulatory Submission of a BLA or MAA.

SECTION 1.47. “ Regulatory Authority ” means: any federal, national, multinational, state, provincial, or local regulatory agency, department, bureau, or other governmental entity with authority over clinical trials, safety, marketing, pricing and/or sale of any Product, including the FDA in the United States, the EMEA in Europe and the TGA in Australia.

SECTION 1.48. “ Regulatory Submission ” means: the submission to the relevant Regulatory Authority of an appropriate application seeking Approval, registration, license or authorization of any Product, including any relevant marketing authorization application, supplementary application or variation thereof, BLA, MAA, IND, IMPD or equivalent foreign application.

SECTION 1.49. “ Restated License Agreement ” means the Restated License Agreement for IL-21 effective as of January 1, 2003 between ZGEN and NN.

SECTION 1.50. “ RoW ” means: all countries of the world, except those within NA.

SECTION 1.51. “ RoW Net Development Milestones ” means: the net cumulative dollar amount (i.e., after subtracting payments or other reductions creditable to milestones pursuant to the applicable agreement) received by ZGEN from a third party Commercialization Partner as payments for development and regulatory milestone events based on RoW activities related to Products. Notwithstanding the above, [    *    ] ZGEN receives from a Commercialization Partner shall be included in the RoW Net Development Milestones. For the avoidance of doubt, RoW Net Development Milestones do not include royalty payments received by ZGEN pursuant to SECTION 5.1 or RoW Net Sales Milestones.

SECTION 1.52. “ RoW Net Royalty Rate ” means: the net royalty percentage of the RoW Net Sales (i.e., after subtracting royalty offsets and other reductions applied to royalties pursuant to the applicable agreement) received by ZGEN from a third party Commercialization Partner based on annual RoW Net Sales related to Products.

 

SECTION 1.53. “ RoW Net Sales ” means: the gross amount invoiced by ZGEN, its Affiliates, Commercialization Partners and Sublicensees from sales or other dispositions of Products in RoW to any independent third party, less the following with respect to the invoiced Product,

i. any direct or indirect credits and allowances or adjustments, including credits and allowances on account of retroactive price adjustments or on account of rejection, recall or return of Products previously invoiced;

ii. any price reductions, discounts, chargebacks and rebates, as well as administrative, management and other fees, commissions, reimbursements and similar payments to wholesalers and other third party distributors, government authorities, benefit management organizations, health insurance carriers, hospitals, group purchasing organizations and other institutions;

iii. any sales, excise, turnover, value added, or similar taxes and any duties and other governmental charges imposed upon the production, importation, use or sale of Product(s);

iv. applicable transportation, importation, insurance and other handling charges; and

v. the per unit cost of special devices used for administration of Product, comprising the total of (a) the purchase price paid by ZGEN or its Affiliates if such device is purchased from third parties or (b) the fully allocated manufacturing cost of such devices if such devices are manufactured by ZGEN or its Affiliates. Such special devices shall not include conventional devices ( e.g. , tablets, standard syringes, suppositories and/or standard transdermal patches).

Deductions i, ii and iv in the aggregate shall not exceed [    *    ] of the gross amount invoiced for the Product, by ZGEN, or its Affiliates, Commercialization Partner(s) or Sublicensee(s) during any reporting period.

In the event that the Product in RoW is sold as part of a Combination Product (as hereinafter defined) the RoW Net Sales of the Product, for the purposes of determining royalty payments, shall be determined by multiplying the RoW Net Sales of the Combination Product by the fraction, A/(A + B) where A is the average sale price of the Product when sold separately in finished form and B is the average sale price of the Other Active Agents (as hereinafter defined) sold separately in finished form. In the event that the average sale price of the Product or Other Active Agents cannot be determined, RoW Net Sales of the Product, for the purposes of determining royalty payments, shall be determined by multiplying the RoW Net Sales of the Combination Product by the fraction C/(C+D), where C is the average per unit inventory cost of the Product and D is the average per unit inventory cost of the Other Active Agents. Inventory costs shall be determined in accordance with ZGEN’s regular accounting methods.

The fractions set forth in the preceding two paragraphs, as applicable, for a Combination Product shall be calculated once each calendar year, for a country, and shall be used during all

 

applicable royalty reporting periods for the entire calendar year. When determining the average sale price or inventory cost of a Product or Other Active Agents, data for the preceding calendar year shall be used for calculating the applicable fraction; provided, however, that with respect to the first year of RoW Net Sales of a Combination Product for a country when there have not been prior separate sales of the corresponding Product, a reasonable estimate of the applicable fraction shall be used, and an adjustment made after the end of the year for the actual fraction calculated for the year. As used above, the term “Combination Product” means any pharmaceutical product which is comprises a Product and other pharmaceutically active compounds which are not moieties that are the subject of third-party patents pursuant to which royalties are payable to such third-parties in association with any Patent Products commercialized in accordance with this Agreement (“ Other Active Agents ”).

Notwithstanding the foregoing, the RoW Net Sales of a Product in a country shall never be reduced below [    *    ] of the gross amount invoiced for the Combination Product.

Any Product sold or otherwise disposed of in other than an arm’s-length transaction or for other property ( e.g. , barter) shall be deemed invoiced at its fair market value in the country of sale or disposition.

SECTION 1.54. “ RoW Net Sales Milestones ” means: the net cumulative dollar amount (i.e., after subtracting payments or other reductions creditable to such milestones pursuant to the applicable agreement) received by ZGEN from a third party Commercialization Partner for milestones based upon RoW Net Sales of a Product that would exceed a designated dollar amount resulting in a Commercialization Partner being obligated pay to ZGEN a one time fee. For the avoidance of doubt, RoW Net Sales Milestones do not include royalty payments received by ZGEN pursuant to SECTION 5.1 or RoW Net Development Milestones.

SECTION 1.55. “ Second Restated License Agreement ” means the Second Restated License Agreement for IL-21 effective as of January 16, 2009 between ZGEN and NN.

SECTION 1.56. “ Sublicensee ” means: a third party to whom ZGEN has extended rights that it received or reserved under this Agreement. For the avoidance of doubt, a Commercialization Partner is a Sublicensee.

SECTION 1.57. “ Term ” means: the period from the Effective Date of this Agreement through the earlier of the following dates: (i) date on which this Agreement expires or (ii) the date on which this Agreement is terminated.

SECTION 1.58. “ TGA ” means: the Australian Therapeutic Goods Administration or any successor agency thereto.

SECTION 1.59. “ Valid Claim ” means: a claim of a pending Licensed Patent or IL-21 ZGEN Patent Right, or an unexpired, granted Licensed Patent or IL-21 ZGEN Patent Right that has not: (i) been disclaimed, withdrawn, canceled, or abandoned; or (ii) been finally rejected or held invalid by a decision of a patent-granting authority beyond right of review or appeal; or (iii) been

 

held invalid or unenforceable in an unappealable decision of a court or competent body having jurisdiction (including a decision which was appealable, but which was not timely appealed).

SECTION 1.60. “ ZGEN Prosecuted Patents ” shall have the meaning set forth in SECTION 3.4(a).

SECTION 1.61. “ [    *    ] Patents ” shall have the meaning set forth in SECTION 3.5(d).

Where words and phrases are used herein in the singular, such usage is intended to include the plural forms where appropriate to the context and vice versa. The words “ including ,” “ includes ” and “ such as ” are used in a non-limiting sense and have the same meaning as “ including without limitation ” and “ including, but not limited to. ” Herein ” means anywhere in this Agreement. “ Hereunder ”, “ Hereinafter ” and “ hereto ” mean under or pursuant to any provision of this Agreement. References to Articles, Sections and Appendices are to Articles, Sections and Appendices of this Agreement unless otherwise specified. All Appendices annexed hereto or referred to herein are hereby incorporated in and made a part of this Agreement as if set forth in full herein. Any capitalized terms used in any Appendix but not otherwise defined therein, shall have the meaning as defined in this Agreement.

ARTICLE 2

Data and Know-How Transfer

Manufacture, Supply and Technical Transfer

Clinical and Regulatory Affairs

SECTION 2.1. Transfer Activities . NN shall:

 

(a)	transfer the items of Licensed Know-How listed on the IL-21 Protein Transfer Plan in Appendix D to ZGEN or to a third party designated by ZGEN including:

 

(i)

the documentation, data and information to the extent that NN has such documentation, data and information and is not prohibited by applicable law or contract from transferring such documentation, data and information;

 

(ii)

the manufacturing processes (including manufacturing process, stability program and QC assays) and know how for the Common Product to the extent that NN is not prohibited by applicable law or contract from transferring such manufacturing processes and know how for the Common Product; and

 

(iii)

the materials and reagents related to the IL-21 Protein or its testing to the extent that NN has such materials and reagents in its possession and is not prohibited by applicable law or contract from delivering such materials and reagents.

NN and ZGEN agree to use their commercially reasonable efforts to complete all transfers pursuant to this SECTION 2.1 as promptly as practicable following the Effective Date and in any event no later than June 30, 2009.

 

SECTION 2.2. Clinical Supply Transfer . NN shall transfer to ZGEN or to a third party designated by ZGEN the clinical supply of Common Product that is listed on the IL-21 Protein Transfer Plan in Appendix D and which ZGEN requests in writing on or prior to March 31, 2009, except any such clinical supply that is required by NN to complete Ongoing Clinical Trials, at no cost to ZGEN, other than the cost to transfer such clinical supply which shall be borne by ZGEN. NN and ZGEN agree to use their commercially reasonable efforts to complete this transfer as promptly as practicable following the Effective Date and in any event no later than June 30, 2009. Notwithstanding the above, NN shall destroy all of the clinical supply of Common Product that is not required for clinical trials and which ZGEN does not request, in writing on or prior to March 31, 2009 in accordance with this SECTION 2.2, to be transferred to ZGEN or a third party designated by ZGEN.

SECTION 2.3. Oversight . All transfers pursuant to SECTION 2.1 and SECTION 2.2 shall be overseen by the JSC, which may delegate such oversight responsibility on a day-to-day basis to the JPT.

SECTION 2.4. Costs of Manufacturing Process Transfer . ZGEN shall use its commercially reasonable efforts to cause a prospective third party Commercialization Partner to assume [    *    ] costs of the transfer contemplated in SECTION 2.1(a)(ii). If no prospective Commercial Partner agrees to assume [    *    ] costs, NN and ZGEN shall bear their own internal costs incurred in such transfer that have not been assumed by a third party Commercialization Partner, and shall share the external costs of such transfer that have not been assumed by a third party Commercialization Partner on a [    *    ] basis. In no event shall NN bear any internal or external costs for such transfer after June 30, 2009.

SECTION 2.5. Assignment and Ownership of Approvals and Regulatory Submissions . ZGEN shall Control all Approvals and Regulatory Submissions filed by NN with respect to any Product. The JPT will develop a plan for the assignment or transfer by NN to ZGEN of all of NN’s Regulatory Submissions and Approvals relating to the Product, which shall provide for such assignment or transfer no later than June 30, 2009 and which the parties shall carry out once such plan has been approved by the JSC. No later than June 30, 2009, NN shall assign to ZGEN all Regulatory Submissions and Approvals related to Products, or close out such Regulatory Submissions and Approvals at ZGEN’s written request, which written request ZGEN shall provide to NN no later than March 31, 2009. The parties agree to use their commercially reasonable efforts and shall cooperate and agree to execute any documents necessary to give effect to the foregoing, as promptly as practicable following the Effective Date and in any event no later than June 30, 2009.

SECTION 2.6. Ongoing Clinical Trials . At its sole cost and expense, NN shall continue administering and supplying Ongoing Clinical Trials until the date on which the last Ongoing Clinical Trial has ended and NN’s obligations under this SECTION 2.6 have been fulfilled. Notwithstanding the above, NN shall not initiate any new clinical trials for any Products. In connection with administering and supplying the Ongoing Clinical Trials, NN shall:

 

(a)	fulfill all obligations for such Ongoing Clinical Trials as required by the relevant Regulatory Authorities; and

 

(b)

shall comply with all reporting and regulatory obligations to ZGEN in accordance with SECTIONS 3.3(c)(i) and 3.3(c)(ii), 3.3(d) (as it relates to SECTION 3.3(c)(ii)(B)), 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 4.10, 4.11 of the Cross-License Agreement for each Ongoing Clinical Trial until such obligations are terminated as described herein. The provisions of the Cross-License Agreement identified in this SECTION 2.6(b) shall survive the termination of the Cross-License Agreement until ZGEN has received the last report relating thereto in accordance with SECTION 3.3(c)(ii) of the Cross-License Agreement, and such provisions shall terminate without further action on the part of either of the parties as of the date on which ZGEN has received such last report.

SECTION 2.7. Clinical Data Publication . ZGEN acknowledges and agrees that NN shall be free to publish the results of the Ongoing Clinical Trials in accordance with NN’s internal publication policies provided or summarized to ZGEN prior to ZGEN’s review of such publication as described in this SECTION 2.7. Notwithstanding the above, NN shall furnish ZGEN with copies of all proposed joint oral, written, graphic or electronic public disclosures relating to the Ongoing Clinical Trials. ZGEN may review such proposed disclosure for a period not to exceed thirty (30) days prior to submission for publication or presentation to ensure that its Confidential Information is not inadvertently disclosed. In order to fully protect the rights of both parties, any contemplated publication or other public disclosure containing the details of an invention, whether or not patentable, may be withheld for an additional period of ninety (90) days or until a patent application is filed thereon, whichever is first in time.

SECTION 2.8. Clinical Transfer .

 

(a)

The JPT will develop a plan for transfer from NN to ZGEN of all of NN’s pre-clinical activities, clinical trials, Regulatory Submissions and Approvals, such plan shall be approved by the JSC and, following such approval, the parties shall agree to use their commercially reasonable efforts to carry out such transfer as soon as practicable and in any event no later than June 30, 2009.

 

(b)	ZGEN shall Control all subsequent clinical trials related to Products that may arise out of any existing clinical trials related to Products.

SECTION 2.9. Right to Submit Information Exchanged . NN grants to ZGEN the right to submit to Regulatory Authorities any data received under this Agreement.

SECTION 2.10. Data Protection . The parties agree to comply with any applicable federal, state and local laws and regulations, including all applicable federal, state and local laws and regulations relating to the privacy of patient health information, including the Standards for Individually Identifiable Health Information, 45 C.F.R. parts 160 and 164; the EU Data Protection Directive and any other applicable national laws related to the privacy of patient health information.

SECTION 2.11. Assistance and Cooperation . With regard to the documentation transferred to ZGEN by NN as contemplated by this ARTICLE, prior to December 31, 2009 NN shall render such reasonable assistance to ZGEN as ZGEN may reasonably request as follows:

 

(a)	to enable ZGEN to comply with any law applicable to any Product;

 

(b)	to aid in Regulatory Submissions and Product Approval;

 

(c)	to address communications and inquiries from Regulatory Authorities; and

 

(d)	to allow access and aid in the inspection of sites if required by a Regulatory Authority.

Such reasonable assistance may include promptly exchanging necessary data and information, executing documents, providing reports and summaries and performing such other acts as may be necessary in connection with achieving (a) through (d) above. Any assistance provided under this SECTION 2.11 shall be performed at ZGEN’s sole expense and shall include external costs as well as personnel costs incurred by NN, unless otherwise agreed in writing by the parties. NN shall give reasonable consideration to rendering reasonable assistance to ZGEN after December 31, 2009 on a case by case basis and upon such terms and conditions (including as to expense reimbursement) as may be agreed between the parties at such time.

SECTION 2.12. Cooperation and Transfer Obligations . The parties shall use their commercially reasonable efforts, and shall cooperate and agree to execute any documents necessary to give effect to the purposes of this ARTICLE. Provided that NN exerts its commercially reasonable efforts to fulfill its obligations according to the dates and timelines stipulated in this ARTICLE, NN shall have no obligations (whether obligations to bear any internal or external costs or otherwise) in respect of the transfer activities and activities ancillary thereto that are set forth in SECTIONS 2.1, 2.2, 2.4, 2.5, 2.8 and 2.11 beyond the applicable dates specified therein.

ARTICLE 3

Rights to IL-21 Protein Intellectual Property

SECTION 3.1. Ownership of Intellectual Property . Nothing in this Agreement shall affect the ownership of any Licensed Patents and Licensed Know-How by NN or its Affiliates. Nothing in this Agreement shall affect the ownership of any IL-21 ZGEN Patent Rights and IL-21 ZGEN Know-How by ZGEN or its Affiliates.

SECTION 3.2. License . Subject to the terms of this ARTICLE, NN hereby grants ZGEN an exclusive royalty-bearing (subject to SECTION 3.3), license (including the right to sublicense) in RoW under the Licensed Patents and Licensed Know-How to make, have made, conduct research, develop (including clinical development), use, sample, promote, manufacture, market, sell, offer to sell, have sold, distribute, import and export Products and IL-21 Protein; provided, however, that the foregoing license for Licensed Know-How shall become non-exclusive on a country-by-country basis after all Licensed Patents covering the Product or IL-21 Protein in any such country expire. The parties agree to execute any documents necessary to give effect to the foregoing, if required by applicable law.

 

SECTION 3.3. Reservation of Right . NN reserves for itself, its Affiliates, commercialization partners and sublicensees, from the exclusive license in RoW it granted in SECTION 3.2, the worldwide nonexclusive right to make and use the IL-21 Protein only as required to develop (including to clinically develop), produce and commercialize products based on IL-21 Embodiments, so long as any such product resulting from such activities is sold only in RoW during the term of this Agreement.

SECTION 3.4. Patent Prosecution .

 

(a)	ZGEN Prosecuted Patents. ZGEN shall be solely responsible at its sole cost and expense, for the filing and prosecution of any and all patent applications (including opposition and interference proceedings) and for the mai